AstraZeneca Pharma gets nod to sell immunotherapy drug Durvalumab; stock surges

AstraZeneca Pharma’s stock surged 12.6% on Tuesday to hit a 52-week high of ₹7,595.00 after the company received an approval from the Central Drugs Standard Control Organisation to import and distribute Durvalumab (Imfinzi).

The approval has been received for Durvalumab infusion in two dosages—120 mg/2.4 mL and 500 mg/10 mL.

At the time of reporting, the pharma major’s stock was up 12.36% at ₹7,580.00 apiece on the BSE. The stock opened higher today at ₹6,900, in sync with the strong broader market, against the previous close price of ₹6,746.45. The company’s market cap stood at ₹18,950 crore. Over the past month, the stock surged 10.31%, climbed 49.17% in the last six months, and gained 34.30% year-to-date (YTD).

Patients with resectable non-small cell lung cancer who have tumours larger than 4 cm or cancer in the lymph nodes may receive Durvalumab. Additionally, it is suitable for those without known mutations in the epidermal growth factor receptor or rearrangements in anaplastic lymphoma kinase, according to the filings.

The company says Durvalumab, when combined with chemotherapy and used as neoadjuvant treatment followed by ‘Imfinzi’ as monotherapy post-surgery, is intended for treating patients with resectable NSCLC (Non-Small Cell Lung Cancer) without EGFR (Epidermal Growth Factor Receptor) mutations or ALK (Anaplastic Lymphoma Kinase) rearrangements.

“Durvalumab (IMFINZI) in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements,” the company states.

The launch of Durvalumab in India is contingent upon further statutory approvals, it says.

The British-Swedish pharmaceutical firm employees over 3,800 people in India. AstraZeneca Pharma India gained prominence globally for its role in developing the Oxford–AstraZeneca COVID-19 vaccine.

It launched Tremelimumab (Imjudo) in India, scheduled for launch in October 2024.

It had also received import and market permission in Form CT-20 from the Drugs Controller General of India for Tremelimumab (Imjudo) concentrate, which is available in 20 mg/ml strength (in 25 mg/1.25 ml and 300 mg/15 ml single-dose vials) and is administered intravenously, it said. Tremelimumab (Imjudo), when combined with Durvalumab (Imfinzi), is indicated for treating patients with unresectable hepatocellular carcinoma (uHCC).

The pharmaceutical company revealed a net loss of ₹11.79 crore for the first quarter ending June 30, 2024, despite a 31% increase in revenue from operations, which reached ₹387.5 crore. In contrast, the drug manufacturer's profit stood at ₹54 crore for the April-June quarter of the previous fiscal year.